Hightop Health · 7 hours ago
Clinical Research Coordinator
Marietta Psych Atlanta Clinic, Marietta, GA, US
Full-time
Hybrid
Senior Level
5+ years expHightop Health is dedicated to advancing mental health treatments through rigorous clinical trials. They are seeking a Clinical Research Coordinator responsible for coordinating and conducting multiple clinical research trials, providing administrative and clinical support while ensuring compliance with study protocols and regulatory requirements.
Health CareMedicalMental Health
Responsibilities
Coordinate and conduct protocol-required study visits for research participants, including completion of all protocol-specified assessments (e.g., vital signs, ECGs, lab collection, questionnaires) within defined time windows
Ensure each study visit is conducted according to the approved protocol, investigator instructions, and site standard operating procedures (SOPs)
Support the PI in ensuring subject safety and data integrity throughout the course of each study
Perform and document protocol-required clinical assessments such as vital signs, ECG collection, adverse event (AE) monitoring, and concomitant medication review, within scope of training and credentialing
Collect, process, and ship biological specimens (e.g., blood, urine) per protocol and IATA guidelines, including proper labeling, handling, packaging, and documentation
Administer protocol-specific questionnaires and diaries, providing instructions to participants and ensuring complete, accurate data capture
Assist practice staff with clinical tasks as directed, including blood pressure collection, ECG collection, specimen collection and processing, and administering injections within scope and policy
Manage and document the proper handling, packing, and scheduled pick-up of biohazard and regulated medical waste in accordance with applicable regulations and Hightop Health policies
Accurately document study-related information in source documents and research charts, following GCP and Hightop Health documentation standards
Complete, review, and maintain case report forms (CRFs/eCRFs) for accuracy and completeness; reconcile data against source documents and resolve queries in collaboration with the PI and sponsor/CRO
Ensure timely and accurate documentation and reporting of all non-serious and serious adverse events (AEs/SAEs) and concomitant medications as required by protocol, sponsor, IRB, and regulatory requirements
Maintain essential regulatory documents and study files in accordance with FDA regulations, GCP, sponsor expectations, and Hightop Health SOPs
Qualification
Required
BA/BS in health science, social science, business, nursing, or related field required; OR BS in Nursing with current RN license, as applicable to Hightop Health needs and state regulations
Current BLS/CPR certification required or obtained within a timeframe defined by Hightop Health
Current GCP and IATA training required, with timely renewals per regulatory and Hightop Health requirements
Minimum of five (5) years of experience in clinical research coordinating investigational clinical trials, with familiarity in research workflows, regulatory requirements, and clinical documentation practices
Demonstrated experience conducting subject visits, collecting clinical data, handling lab specimens, and performing protocol-specific assessments
Working knowledge of FDA regulations, ICH-GCP guidelines, IRB requirements, and HIPAA as they relate to clinical research
Proficiency with electronic data capture systems (EDC), clinical trial management systems (CTMS), and standard office software (e.g., email, Microsoft Office)
Strong written and verbal communication skills; ability to explain complex information to participants and colleagues clearly and respectfully
Highly organized, detail-oriented, and capable of managing multiple studies and priorities simultaneously
Demonstrates professionalism, confidentiality, and discretion in all interactions
Preferred
Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) from recognized bodies (e.g., SOCRA, ACRP) preferred; willingness to obtain certification within a timeframe defined by Hightop Health is desirable
Benefits
Medical Benefits
Robust Paid Time Off
Paid Holidays
Retirement Plan and more!
Company
Hightop Health
Hightop Health offers comprehensive outpatient mental health services, focusing on integrative care for mind and body health.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase